“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy

Emina Torlakovic; Hyun J. Lim; Julien Adam; Penny Barnes; Gilbert Bigras; Anthony W.H. Chan; Carol C. Cheung; Jin Haeng Chung; Christian Couture; Pierre O. Fiset; Daichi Fujimoto; Gang Han; Fred R. Hirsch; Marius Ilie; Diana Ionescu; Chao Li; Enrico Munari; Katsuhiro Okuda; Marianne J. Ratcliffe; David L. Rimm; Catherine Ross; Rasmus Røge; Andreas H. Scheel; Ross A. Soo; Paul E. Swanson; Maria Tretiakova; Ka F. To; Gilad W. Vainer; Hangjun Wang; Zhaolin Xu; Dirk Zielinski; Ming Sound Tsao

doi:10.1038/s41379-019-0327-4

“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy

Emina Torlakovic, Hyun J. Lim, Julien Adam, Penny Barnes, Gilbert Bigras, Anthony W.H. Chan, Carol C. Cheung, Jin Haeng Chung, Christian Couture, Pierre O. Fiset, Daichi Fujimoto, Gang Han, Fred R. Hirsch, Marius Ilie, Diana Ionescu, Chao Li, Enrico Munari, Katsuhiro Okuda, Marianne J. Ratcliffe, David L. RimmCatherine Ross, Rasmus Røge, Andreas H. Scheel, Ross A. Soo, Paul E. Swanson, Maria Tretiakova, Ka F. To, Gilad W. Vainer, Hangjun Wang, Zhaolin Xu, Dirk Zielinski, Ming Sound Tsao

Research output: Contribution to journal › Review article › peer-review

149 Citations (Scopus)

Abstract

Different clones, protocol conditions, instruments, and scoring/readout methods may pose challenges in introducing different PD-L1 assays for immunotherapy. The diagnostic accuracy of using different PD-L1 assays interchangeably for various purposes is unknown. The primary objective of this meta-analysis was to address PD-L1 assay interchangeability based on assay diagnostic accuracy for established clinical uses/purposes. A systematic search of the MEDLINE database using PubMed platform was conducted using “PD-L1” as a search term for 01/01/2015 to 31/08/2018, with limitations “English” and “human”. 2,515 abstracts were reviewed to select for original contributions only. 57 studies on comparison of two or more PD-L1 assays were fully reviewed. 22 publications were selected for meta-analysis. Additional data were requested from authors of 20/22 studies in order to enable the meta-analysis. Modified GRADE and QUADAS-2 criteria were used for grading published evidence and designing data abstraction templates for extraction by reviewers. PRISMA was used to guide reporting of systematic review and meta-analysis and STARD 2015 for reporting diagnostic accuracy study. CLSI EP12-A2 was used to guide test comparisons. Data were pooled using random-effects model. The main outcome measure was diagnostic accuracy of various PD-L1 assays. The 22 included studies provided 376 2×2 contingency tables for analyses. Results of our study suggest that, when the testing laboratory is not able to use an Food and Drug Administration-approved companion diagnostic(s) for PD-L1 assessment for its specific clinical purpose(s), it is better to develop a properly validated laboratory developed test for the same purpose(s) as the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic, than to replace the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic with a another PD-L1 Food and Drug Administration-approved companion diagnostic that was developed for a different purpose.

Original language	English
Pages (from-to)	4-17
Number of pages	14
Journal	Modern Pathology
Volume	33
Issue number	1
DOIs	https://doi.org/10.1038/s41379-019-0327-4
Publication status	Published - Jan 1 2020
Externally published	Yes

Bibliographical note

Funding Information:
Funding This meta-analysis was undertaken as part of a larger work relating to the generation of evidence-based guidelines for predictive PD-L1 testing in immuno-oncology. As such, a part of its funding was derived from the same source as its parent project, which was the Canadian Association of Pathologists - canadienne des pathologistes (CAP-ACP), via unrestricted educational grants from AstraZeneca Canada, BMS Canada, Merck Canada, and Roche Diagnostics. None of the sources of grant support had any role in the design of the study, selection of included studies, study analysis, discussion or conclusions, nor in the decision whether the paper would be submitted for publication and where the paper will be submitted for publication. However, where the authors of published studies that were included in the manuscript were also associated with sources of grant support, these authors did have a role in discussion of results.

Publisher Copyright:
© 2019, The Author(s).

ASJC Scopus Subject Areas

Pathology and Forensic Medicine

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10.1038/s41379-019-0327-4

Cite this

Torlakovic, E., Lim, H. J., Adam, J., Barnes, P., Bigras, G., Chan, A. W. H., Cheung, C. C., Chung, J. H., Couture, C., Fiset, P. O., Fujimoto, D., Han, G., Hirsch, F. R., Ilie, M., Ionescu, D., Li, C., Munari, E., Okuda, K., Ratcliffe, M. J., ... Tsao, M. S. (2020). “Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy. Modern Pathology, 33(1), 4-17. https://doi.org/10.1038/s41379-019-0327-4

Torlakovic, E, Lim, HJ, Adam, J, Barnes, P, Bigras, G, Chan, AWH, Cheung, CC, Chung, JH, Couture, C, Fiset, PO, Fujimoto, D, Han, G, Hirsch, FR, Ilie, M, Ionescu, D, Li, C, Munari, E, Okuda, K, Ratcliffe, MJ, Rimm, DL, Ross, C, Røge, R, Scheel, AH, Soo, RA, Swanson, PE, Tretiakova, M, To, KF, Vainer, GW, Wang, H, Xu, Z, Zielinski, D & Tsao, MS 2020, '“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy', Modern Pathology, vol. 33, no. 1, pp. 4-17. https://doi.org/10.1038/s41379-019-0327-4

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abstract = "Different clones, protocol conditions, instruments, and scoring/readout methods may pose challenges in introducing different PD-L1 assays for immunotherapy. The diagnostic accuracy of using different PD-L1 assays interchangeably for various purposes is unknown. The primary objective of this meta-analysis was to address PD-L1 assay interchangeability based on assay diagnostic accuracy for established clinical uses/purposes. A systematic search of the MEDLINE database using PubMed platform was conducted using “PD-L1” as a search term for 01/01/2015 to 31/08/2018, with limitations “English” and “human”. 2,515 abstracts were reviewed to select for original contributions only. 57 studies on comparison of two or more PD-L1 assays were fully reviewed. 22 publications were selected for meta-analysis. Additional data were requested from authors of 20/22 studies in order to enable the meta-analysis. Modified GRADE and QUADAS-2 criteria were used for grading published evidence and designing data abstraction templates for extraction by reviewers. PRISMA was used to guide reporting of systematic review and meta-analysis and STARD 2015 for reporting diagnostic accuracy study. CLSI EP12-A2 was used to guide test comparisons. Data were pooled using random-effects model. The main outcome measure was diagnostic accuracy of various PD-L1 assays. The 22 included studies provided 376 2×2 contingency tables for analyses. Results of our study suggest that, when the testing laboratory is not able to use an Food and Drug Administration-approved companion diagnostic(s) for PD-L1 assessment for its specific clinical purpose(s), it is better to develop a properly validated laboratory developed test for the same purpose(s) as the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic, than to replace the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic with a another PD-L1 Food and Drug Administration-approved companion diagnostic that was developed for a different purpose.",

author = "Emina Torlakovic and Lim, {Hyun J.} and Julien Adam and Penny Barnes and Gilbert Bigras and Chan, {Anthony W.H.} and Cheung, {Carol C.} and Chung, {Jin Haeng} and Christian Couture and Fiset, {Pierre O.} and Daichi Fujimoto and Gang Han and Hirsch, {Fred R.} and Marius Ilie and Diana Ionescu and Chao Li and Enrico Munari and Katsuhiro Okuda and Ratcliffe, {Marianne J.} and Rimm, {David L.} and Catherine Ross and Rasmus R{\o}ge and Scheel, {Andreas H.} and Soo, {Ross A.} and Swanson, {Paul E.} and Maria Tretiakova and To, {Ka F.} and Vainer, {Gilad W.} and Hangjun Wang and Zhaolin Xu and Dirk Zielinski and Tsao, {Ming Sound}",

note = "Funding Information: Funding This meta-analysis was undertaken as part of a larger work relating to the generation of evidence-based guidelines for predictive PD-L1 testing in immuno-oncology. As such, a part of its funding was derived from the same source as its parent project, which was the Canadian Association of Pathologists - canadienne des pathologistes (CAP-ACP), via unrestricted educational grants from AstraZeneca Canada, BMS Canada, Merck Canada, and Roche Diagnostics. None of the sources of grant support had any role in the design of the study, selection of included studies, study analysis, discussion or conclusions, nor in the decision whether the paper would be submitted for publication and where the paper will be submitted for publication. However, where the authors of published studies that were included in the manuscript were also associated with sources of grant support, these authors did have a role in discussion of results. Publisher Copyright: {\textcopyright} 2019, The Author(s).",

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doi = "10.1038/s41379-019-0327-4",

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AU - Torlakovic, Emina

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AU - Adam, Julien

AU - Barnes, Penny

AU - Bigras, Gilbert

AU - Chan, Anthony W.H.

AU - Cheung, Carol C.

AU - Chung, Jin Haeng

AU - Couture, Christian

AU - Fiset, Pierre O.

AU - Fujimoto, Daichi

AU - Han, Gang

AU - Hirsch, Fred R.

AU - Ilie, Marius

AU - Ionescu, Diana

AU - Li, Chao

AU - Munari, Enrico

AU - Okuda, Katsuhiro

AU - Ratcliffe, Marianne J.

AU - Rimm, David L.

AU - Ross, Catherine

AU - Røge, Rasmus

AU - Scheel, Andreas H.

AU - Soo, Ross A.

AU - Swanson, Paul E.

AU - Tretiakova, Maria

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N2 - Different clones, protocol conditions, instruments, and scoring/readout methods may pose challenges in introducing different PD-L1 assays for immunotherapy. The diagnostic accuracy of using different PD-L1 assays interchangeably for various purposes is unknown. The primary objective of this meta-analysis was to address PD-L1 assay interchangeability based on assay diagnostic accuracy for established clinical uses/purposes. A systematic search of the MEDLINE database using PubMed platform was conducted using “PD-L1” as a search term for 01/01/2015 to 31/08/2018, with limitations “English” and “human”. 2,515 abstracts were reviewed to select for original contributions only. 57 studies on comparison of two or more PD-L1 assays were fully reviewed. 22 publications were selected for meta-analysis. Additional data were requested from authors of 20/22 studies in order to enable the meta-analysis. Modified GRADE and QUADAS-2 criteria were used for grading published evidence and designing data abstraction templates for extraction by reviewers. PRISMA was used to guide reporting of systematic review and meta-analysis and STARD 2015 for reporting diagnostic accuracy study. CLSI EP12-A2 was used to guide test comparisons. Data were pooled using random-effects model. The main outcome measure was diagnostic accuracy of various PD-L1 assays. The 22 included studies provided 376 2×2 contingency tables for analyses. Results of our study suggest that, when the testing laboratory is not able to use an Food and Drug Administration-approved companion diagnostic(s) for PD-L1 assessment for its specific clinical purpose(s), it is better to develop a properly validated laboratory developed test for the same purpose(s) as the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic, than to replace the original PD-L1 Food and Drug Administration-approved immunohistochemistry companion diagnostic with a another PD-L1 Food and Drug Administration-approved companion diagnostic that was developed for a different purpose.

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“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy

Abstract

Bibliographical note

ASJC Scopus Subject Areas

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